(83 days)
Post-traumatic joint contracture which has resulted in loss of range of motion: fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions and management of comminuted intra-articular fractures of the distal radius.
SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods, articulating and telescoping components), and connection elements (rings, plates, and posts) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
The provided text describes a 510(k) premarket notification for a Reprocessed External Fixation Device, not an AI or imaging device, therefore many of the requested fields are not applicable. The device is a reprocessed medical device, and the focus of the submission is to demonstrate its substantial equivalence to an original, legally marketed predicate device (the Smith & Nephew Original Ilizarov® External Fixation System).
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for a reprocessed medical device like this external fixation device are generally focused on demonstrating that the reprocessed device performs functionally and safely to the same standards as the original device, and that the reprocessing itself is safe and effective (e.g., proper cleaning and sterilization).
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Functional Characteristics | Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. |
| Process Validation (Cleaning) | Process validation testing was performed to validate the cleaning procedure. |
| Manufacturing Process Quality | The manufacturing process includes visual and validated functional testing of all products produced. |
| Substantial Equivalence | The Reprocessed External Fixation Devices are substantially equivalent to the Smith & Nephew Original Ilizarov® external fixation devices based upon similarities in functional design (principle of operation), materials, indications for use, and methods of construction. |
Study Details
Given that this is a 510(k) for a reprocessed non-AI medical device, the typical "study" involves engineering and process validation testing rather than large-scale clinical trials or AI performance evaluations as would be expected for a diagnostic software device.
-
Sample size used for the test set and the data provenance:
- The document mentions "Representative samples of reprocessed external fixation constructs were tested." No specific numerical sample size is provided in the text.
- Data Provenance: Not explicitly stated, but implicitly from SterilMed, Inc.'s internal testing labs, likely in the USA. These tests would be prospective in the sense that they were conducted specifically for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device and the "ground truth" is defined by established engineering and medical device performance standards for the predicate device, not by expert interpretation of data like images. No expert consensus on performance is described beyond regulatory review.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to discrepancies in expert readings for diagnostic algorithms. For a physical device, performance is typically assessed against quantifiable engineering specifications derived from the predicate device.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This type of study is for evaluating the impact of AI on human reader performance, which doesn't apply to a reprocessed external fixation device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical, reprocessed medical device, not an algorithm. The standalone performance would refer to the device's functional integrity as tested in the lab, which was done ("Representative samples...were tested to demonstrate appropriate functional characteristics.").
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this type of device is the established functional and safety specifications of the original (predicate) device, and adherence to those specifications through engineering tests (e.g., mechanical strength, fatigue, material integrity) and process validation (e.g., cleaning efficacy, sterilization).
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set is used for this type of device submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.